Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers

Novo Nordisk A/S39 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors Healthy

Interventions

activated recombinant human factor VIIDRUG

Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits

placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Caucasian or Japanese * Healthy as defined by medical history, physical and biological examinations Exclusion Criteria: * History of allergy or hypersensitivity reaction to any medication * History or presence of any organic disorder likely to modify absorption, distribution or elimination of the medication * Alcohol or substance abuse disorder * Subject in his exclusion period in the Healthy Volunteers National Register of the French Ministry of Health

Locations (1)

Novo Nordisk Investigational Site

Paris, France

Outcomes

Primary Outcomes

Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours

Secondary Outcomes

Mean residence time (MRT)

Maximum plasma concentration (Cmax)

Time to reach maximum plasma concentration (tmax)

Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time)

Adverse events

Data from ClinicalTrials.gov

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